BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 19382659 · Received May 23, 2024

    Report

    Report Number
    3011610434-2024-00003
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Report Date
    May 23, 2024
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    OWQ
    UDI-DI
    10841898123252
    PMA / PMN Number
    K202042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON 26-APR-2024 OF A REPORT FROM CENTRAL MAINE MEDICAL CENTER OF A REPROCESSED VIEWFLEX XTRA ICE DIAGNOSTIC ULTRASOUND CATHETER THAT WAS BENT. THE DEVICE WAS REPORTED TO HAVE BEEN INSERTED TO VIEW HEART CHAMBERS FOR SEPTUM CROSSING WHEN THE ISSUE OCCURRED. THE PATIENT CONDITION BEFORE AND AFTER THE EVENT WAS REPORTED TO BE STABLE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO INJURY WAS REPORTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, WITH THE INFORMATION AVAILABLE, INNOVATIVE HEALTH CANNOT CONFIRM ANY PERFORMANCE ISSUES WITH THE REPORTED DEVICE.

    Description of Event or Problem · 0

    THE DEVICE WAS REPORTED TO BE BENT. THE FAILURE WAS REPORTED TO HAVE OCCURRRED AT INSERTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603311 N/A DIAGNOSTIC ULTRASOUND CATHETER OWQ INNOVATIVE HEALTH, LLC. D087031 10841898123252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown